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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
| University Hospital of Leuven Leuven | OTHER |
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The aim of this clinical study is to investigate the effect of a ginger formulation as a dietary supplement on gastrointestinal complaints in healthy adults.
The effect of this formula will be compared to a placebo after 8 weeks of consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger formula | Experimental | 100 mg of ginger formula per capsule 2 capsules per day during 8 weeks |
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| Placebo formula | Placebo Comparator | 2 capsules per day during 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger formula | Dietary Supplement | supplement delivering a minimum of 20 mg of gingeroids / d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leuven Postprandial Distress scale (LPDS) | The LPDS is a questionnaire consisting of eight items: early satiation, postprandial fullness, upper abdominal bloating, epigastric pain, epigastric burning, nausea, belching and heartburn. Each symptom will be rated on a 5-point Likert-type scale: absent=0, mild=1, moderate=2, severe=3 and very severe=4 over a period of one day. | daily, up to 66 days after the day of inclusion. from the day after inclusion until 8 weeks after randomization visit |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Nepean Dyspepsia Index (SF-NDI) | The Short Form (SF) Nepean Dyspepsia Index is a 10-item questionnaire with 5 sub-scales each examining the influence of dyspepsia on domains of health in subjects, namely tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease symptoms and interference with work/study, with each sub-scale containing two items. Each item is measured by a 5-point Likert scale ranging from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely) scores. |
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Inclusion Criteria:
Men and women aged 18-65 years
Body Mass Index (BMI) 18.5 - 30.0 kg/m2 (limits included)
Otherwise healthy subjects with Postprandial Distress Syndrome (PDS) as defined by ROME IV criteria: Must include one or both of the following criteria* at least 3 days a week: - Bothersome postprandial fullness (i.e. severe enough to impact on usual activities)
Bothersome early satiation (i.e. severe enough to prevent finishing a regular size meal)
*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis with no apparent evidence of organic, systemic or metabolic disease or structural disease by standard clinical examination by the investigator at V0 that is likely to explain the complaints
Documented Helicobacter pylori negative subjects according to a validated previous test (histological, breath, stool antigen or serological test) in the last 5 years or if not, with a rapid assay realized during V0
Negative urine pregnancy test for women in childbearing age at V0 At V1, after 1-week diary completion, mean "PDS score" on LPDS scale ≥ 1 and <3 (mild and moderate) As per this randomization criterion, any subjects with a "PDS score" of ≥3 (severe or very severe) or <1 (too low) at V1 will be withdrawn from the study.
For assessment of PDS, the last 7 consecutive days before V1 should be used to calculate the score.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Gensch | Contact | 49 176 44435206 | agensch@a-r.com | |
| Geraldine Krausz, phD | Contact | geraldine.krausz@givaudan.com |
| Name | Affiliation | Role |
|---|---|---|
| Tim Vanuytsel, Pr | UZ Leuven | Principal Investigator |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized placebo controlled double blind trial
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| Placebo | Dietary Supplement | arabic gum |
|
| monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months |
| Overall Treatment Effect (OTE) | Subjects instructed to answer the question: "How were your gastric symptoms during the past week in comparison with the baseline period preceding the intake of the food supplement? " (7 point Likert scale) | monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months |
| Gastric emptying | The gastric emptying breath test is a standard tool to measure gastric emptying rate in subjects with dyspeptic symptoms. After eating, subjects will provide a breath sample and will score the severity (0: absent - 4: very severe) of 6 epigastric symptoms (fullness, bloating, nausea, epigastric pain, burning, and belching) every 15 minutes until 4 hours postprandially. | twice : basal at visit V1 (randomization) and after 2 months |
| Chalder fatigue scale | Each of the 11 items are answered on a 4-point scale ranging from asymptomatic to maximum symptomatology. Using the Likert scoring method, responses on the extreme left receive a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). The Likert scoring system allows for means and distributions to be calculated for both the global total as well as the two sub-scales. | monthly, from the day of randomization visit (V1) till end of study visit (V3) after 8 weeks |
| Perceived stress scale (PSS-10) | The PSS-10 is a self-questionnaire comprising 10 items and allowing each item to be evaluated on its frequency of occurrence during the previous month using a 5-point scale ranging from 0 = never to 4 = very often (Cohen & Williamson, 1988; Bellinghausen, 2009). The PSS-10 consists of 10 items from the PSS-14 (items 1, 2, 3, 6, 7, 8, 9, 10, 11, and 14). The PSS-10 allows the assessment of perceived stress without any loss of psychometric quality. PSS-10 scores are obtained by reversing responses (e.g., Never = 4, Almost Never = 3, Sometimes = 2, Fairly Often = 1, Very Often= 0) to the four positively stated items (items 4, 5, 7 and 8 from the PSS-10, corresponding to items 6, 7, 9 and 10 from the original PSS-14) and then summing across all scale items. Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress. | monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months |